The goal of this pilot study is to develop and test a behavioral intervention to improve the health of adults with refractory chronic low back pain (CLBP) and reduce pain medication, especially prescription opioid use. CLBP is one of the most common, costly and disabling conditions, and is often refractory to treatment. Mindfulness meditation is a promising treatment for chronic pain, mental health and addictive disorders. This randomized controlled trial (RCT) will test the hypotheses (H) that at 26 weeks, meditation group participants (meditation + standard of care, SOC) compared to those in a wait-list control group (SOC alone) will:

Averaged pain is the average of 4 responses on a 0-10 numerical rating scale (0=no pain; 10=worst possible pain) from the Brief Pain Inventory (BPI): 1) describe your pain at its worst in the last week 2) describe your pain at its least in the last week 3) describe your pain on the average 4) describe your pain right now.

This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased pain and negative values indicating decreased pain.

Averaged pain is the average of 4 responses on a 0-10 numerical rating scale (0=no pain; 10=worst possible pain) from the Brief Pain Inventory (BPI): 1) describe your pain at its worst in the last week 2) describe your pain at its least in the last week 3) describe your pain on the average 4) describe your pain right now.

This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased pain and negative values indicating decreased pain.

Opioid use was measured using the Timeline Followback Method which looked at the past 28 days of opioid use. Opioid use was standardized [daily morphine-equivalent dose (MED)] across different opioids for each participant.

This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased opioid use and negative values indicating decreased opioid use.

Opioid use was measured using the Timeline Followback Method which looked at the past 28 days of opioid use. Opioid use was standardized [daily morphine-equivalent dose (MED)] across different opioids for each participant.

This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased opioid use and negative values indicating decreased opioid use.

A benefit/cost ratio will be calculated using self-reported lost work time (number of days), health care utilization (number of clinic or emergency department visits; number of hospital days) and participant costs (number of minutes spent on intervention; pain medication cost, HRQoL) using a) the Economic Outcomes Survey and b) the HRQoL survey, the EuroQol EQ-5D-5L.

Chronic low back pain (CLBP) is one of the most common, costly and disabling conditions. Treatment for refractory CLBP often includes opioid therapy even though it is often only marginally effective. Prescription opioid abuse is a national epidemic; development of safe, effective non-addictive therapies for chronic pain is a national priority. Mindfulness meditation is a promising, safe treatment for chronic pain, mental health and addictive disorders. No study has evaluated the potential of meditation to improve health, decrease daily pain medication, including opioid, dose or modify CLBP on a biological level in adults with opioid-treated refractory CLBP.

This unblinded 26-week pilot RCT will test methods feasibility and potential efficacy of meditation in improving health-related quality of life (HRQoL) and reducing daily pain medication, including opioid, use among opioid-treated CLBP adults. Up to 50 adults with daily CLBP, treated with daily opioids for at least 3 months, will be recruited from outpatient clinic and community settings, and randomly assigned to one of two balanced study arms: meditation + standard of care (SOC) or SOC alone (wait-list control). The CLBP-tailored meditation intervention will consist of a) therapist-led group training in meditation and evidence-based cognitive therapy strategies (two-hours/week for 8 weeks), and b) at-home meditation (30 minutes/day, 6 days/week). Controls will be offered meditation training after study completion.

This innovative study directly addresses national priorities aimed at development of an effective, safe treatment for CLBP and reduction of opioid use. Potential benefits accruing from positive findings include improved quality of life and reduced pain medication, especially opioid, use among patients with refractory CLBP which may result in decreased individual and societal harms that can be associated with opioid therapy; reduced pool of circulating opioids may help alleviate the growing problem of prescription opioid abuse.

Eligibility

Ages Eligible for Study:

21 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Age ≥ 21 years old

Chronic low back pain defined as a daily pain in the lumbosacral region or radiating to the leg (sciatica)

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01775995